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BRIEF TITLE: Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Solid Tumors

Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Solid Tumors


  • Org Study ID: 2018-01
  • Secondary ID:
  • NCT ID: NCT03662204
  • NCT Alias:
  • Sponsor: Exact Sciences Corporation - Industry
  • Source: Exact Sciences Corporation

Brief Summary

The primary objective of this study is to obtain de-identified, clinically characterized, whole blood specimens to evaluate biomarkers associated with cancer for diagnostic assay development.

Detailed Description


Subjects will have been recently diagnosed with an untreated solid tumor. Subjects will have
a blood sample collected at enrollment and provide medical history prior to initiation of
treatment. There will be no further follow-up.

Overal Status Start Date Phase Study Type
Recruiting August 23, 2018 Observational

Primary Outcomes:

Primary Outcome 1 - Measure: Biomarker Evaluation

Primary Outcome 1 - Time Frame: Point in time (one day) blood collection at enrollment

Condition:

  • Breast Cancer
  • Lung Cancer
  • Colorectal Cancer
  • Prostate Cancer
  • Bladder Cancer
  • Uterine Cancer
  • Kidney Cancer
  • Renal Pelvis Cancer
  • Pancreatic Cancer
  • Liver Cancer
  • Stomach Cancer
  • Ovarian Cancer
  • Esophageal Cancer

Eligibility

Criteria:
Inclusion Criteria:

1. Subject is male or female > 18 years of age.

2. Subject has an untreated primary malignancy of breast, lung, colorectal, prostate,
bladder, uterine, kidney/renal pelvis, pancreatic, liver, stomach, ovarian or<br/> esophageal cancer.

3. Subject understands the study procedures and is able to provide informed consent to
participate in the study and authorization for release of relevant protected health
information to the study Investigator.

Exclusion Criteria:

1. Any previous cancer diagnosis within the past 5 years (with the exceptions of basal
cell or squamous cell skin cancers).

2. Chemotherapy and/or radiation therapy within 5 years prior to enrollment/sample
collection.

3. Any treatment for the primary malignancy or sites of metastases. Subject may not have
started neo-adjuvant chemotherapy, neo-adjuvant radiation therapy, immunotherapy or
other treatment and/or surgery prior to blood sample collection.

4. Less than 3 days between fine needle aspiration (FNA) of target pathology and blood
collection.

5. Less than 7 days between biopsy (other than FNA) of target pathology and blood
collection.

6. IV contrast (e.g. CT and MRI) within 1 day [or 24 hours] of blood collection.

7. Individual has a condition the Investigator believes would interfere with his or her
ability to provide informed consent, comply with the study protocol, which might
confound the interpretation of the study results or put the person at undue risk.
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Contact

Name: Alexandra Massoud

Phone: 608-957-5652

Email: amassoud@exactsciences.com

Locations

Facility Status Contact
CARTI Cancer Center
Little Rock, Arkansas 72205
United States
Recruiting Carla Randall
501-906-3012
CRandall@CARTI.com
Sun Research Institute
San Antonio, Texas 78215
United States
Recruiting Beneta Parthiban
210-227-1289
bparthiban@sunresearch.com
Seattle Urology Research Center
Burien, Washington 98166
United States
Recruiting Angel Felipe

surc@comcast.net